ISO 13485 Audit in Bangalore by QualitCert

ISO 13485 is the globally recognized standard for quality management systems in the medical device industry. An ISO 13485 audit is a crucial step to ensure that your organization complies with the requirements of the standard and consistently delivers safe and effective medical devices.

What is an ISO 13485 Audit?

An ISO 13485 audit involves a systematic examination of your company’s processes, procedures, and documentation to verify that they meet the standards set by ISO 13485. This can include evaluating design controls, risk management, production, and post-production activities.

Types of ISO 13485 Audits

1. Internal Audit: Conducted within the organization to assess internal processes and identify areas for improvement.


2. External Audit: Performed by a third-party certification body to confirm compliance and grant certification.


3. Surveillance Audit: Regular audits conducted to ensure ongoing compliance after certification.

QualitCert’s ISO 13485 Audit Services in Bangalore

QualitCert offers comprehensive audit services to medical device companies in Bangalore. Our experienced auditors help you prepare for certification, identify gaps, and implement corrective actions to ensure compliance.

Why Choose QualitCert for ISO 13485 Audits?

• Experienced Auditors: Skilled auditors with deep knowledge of ISO 13485 standards.


• Detailed Gap Analysis: Identification of compliance gaps and suggestions for corrective actions.


• Pre-Audit Support: Guidance and preparation for certification or external audits.